Cleared Traditional

TACTIL EAR (K831501) - FDA 510(k) Clearance

K831501 · Ear Three Systems · Ear, Nose, Throat device
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Aug 1983
Decision
107d
Days
-
Risk

K831501 is an FDA 510(k) clearance for the TACTIL EAR. Classified as Hearing Aid, Tactile (product code LRA).

Submitted by Ear Three Systems. The FDA issued a Cleared decision on August 26, 1983 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K831501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1983
Decision Date August 26, 1983
Days to Decision 107 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 89d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRA Hearing Aid, Tactile
Device Class -